DDrare: Database of Drug Development for Rare Diseases

85. 特発性間質性肺炎
［臨床試験数：514，薬物数：377（DrugBank：108），標的遺伝子数：97，標的パスウェイ数：204］

Searched query = "Idiopathic interstitial pneumonia", "IIPs", "Idiopathic pulmonary fibrosis", "IPF", "Usual interstitial pneumonia", "UIP", "Non-specific interstitial pneumonia", "NSIP", "Acute interstitial pneumonia", "AIP", "Diffuse alveolar damage", "DAD", "COP", "Organizing pneumonia", "OP", "Desquamative interstitial pneumonia", "DIP", "Respiratory bronchiolitis - associated interstitial lung disease", "RB-ILD", "Lymphocytic interstitial pneumonia", "LIP"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = (18)F-FDG; 18F-FDG; 3-[4-(1H-imidazol-1-ylmethyl)phenyl]-5-(2-methylpropyl)thiophene-2-[(N-butyloxylcarbamate)-sulphonamide] sodium salt; 534-1508; 68Ga-BMV101; ACETYLCYSTEINE; ACT-064992; ACT-064992 (macitentan); ART-123; AZAPRED; Acetate; Acetylcysteine; Acetylcysteine Effervescent Tablets; Adult human mesenchymal stem cells; Aerosol interferon-gamma; Air; Alemtuzumab; Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs); Ambrisentan; Antimicrobial therapy: Co-trimoxazole or Doxycycline; Atezolizumab; Autoantibody Reductive Therapy; Autologous Adipose Derived MSCs (ADMSCs); Autologous Stromal Vascular Fraction (SVF); Autologous mesenchymal stem cells derived from bone marrow; Aviptadil; Aviptadil, 66 microgram/mL; Azathioprine; Azathioprine/prednisone; Azithromycin; BBT-877, Multiple doses; BBT-877, Single dose; BG00011; BI 1015550; BIBF 1120; BIBF 1120 ES; BIBF1120; BLD-2660; BMS-986020; BMS-986278; BOSENTAN; Bardoxolone; Bardoxolone methyl; Beclometasone dipropionate; Bevacizumab; Blood sample collection; Bone marrow mesenchymal stem cells; Bosentan; C21; CBDCA; CC; CC-90001; CC-930; CD3/CD19 negative hematopoietic stem cells; CNC; CNTO 888 1 mg/kg; CNTO 888 15 mg/kg; CNTO 888 5 mg/kg; CNTO888; CO; CO-TRIMOXAZOLE; COMPOUND 21; Carbon; Carbon monoxide; Carboplatin; Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03); Co-trimoxazole; Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids; Corticosteroid (prednisolone); Cotrimoxazole; Cravit; Cromoglicate; Cromoglicato disodico; Cromoglycate; Cromolyn; Cromolyn Sodium; Cromolyn sodio (cromoglicato disodico, DSCG); Cromolyn sodium [Disodium Cromoglycate]; Cyclophosphamide; Cyclosphamine; Cysteine; DEX284; DPA; Dabigatran; Dasatinib; Dasatinib + Quercetin; Device: Auto-titrating oxygen system; Device: Centricyte 1000; Device: MRI; Device: Oxymizer® compared to CNC; Dextromethorphan; Diagnostic Test: Metabolomics; Diagnostic Test: PET Imaging; Disodium Cromoglycate [cromolyn sodium]; Disodium cromoglycate (DSCG); Doxycycline; EGCG; ENDOXAN; ESBRIET; EZ-2053; EZ-2053 5mg/kg; Endobronchial infusion of adult mesenchymal stem cells; Endoxan; Epigallocatechin; Epigallocatechin-3-gallate (EGCG); Erivedge; Esbriet; Esbriet® (Pirfenidon); Etanercept; Etoposide; FG-3019; FG-3019 10mg/mL in 10 mL vials; FLUORINE (18F) FLUDEOXYGLUCOSE; Fludarabine; Fludeoxyglucose; Fluimucil; Fluimucil® 600 mg effervescent tablets; Formoterol; Formoterol fumarate dihydrate; Fostair; G-CSF; G321605; G451990; GBT440; GBT440 300 mg capsule; GBT440 300 mg tablet; GC1008; GKT137831; GLPG1205; GLPG1690; GLPG1690 600 mg QD; GS-6624; GSK2126458; GSK3008348; GSK3008348 Nebuliser solution; Gallium68-Dota-Noc; Gefapixant; Granulocyte Colony Stimulating Factor; HEC 68498; HEC585; High dose BIBF 1120 twice daily; Humanized anti-alpha v beta 6 mAb; Hydroxyurea; Hyperoxia; Hyperpolarized 129 Xenon Gas Comparing Idiopathic Pulmonary Fibrosis (IPF) Treatment; Hyperpolarized 129-Xenon gas; IDL-2965 Oral Capsule; INO; INOmax; INOmax 400ppm mol/mol inhalation gas; IW001; Ifenprodil; Iloprost; Iloprost Inhalation Solution (Ventavis); Imatinib; Imatinib Mesylate (Gleevec); Immukin; Inhaled Nitric Oxide; Inhaled Nitric Oxide - 30 mcg/kg IBW/hr; Inhaled Nitric Oxide 5,10,15 mcg/Kg IBW/hr; Inhaled TD139; Inhaled carbon monoxide; Inhaled nitric oxide 75 mcg/kg IBW/hr; Inomax; Interferon Gamma; Interferon alpha oral lozenge; Interferon gamma-1b; Interferon gamma-1b (Actimmune); Interferon-alpha lozenges; Interferon-gamma 1b; Intermediate dose BIBF 1120 twice daily; Jaktinib Dihydrochloride Monohydrate 50mg BID and Mimic tablets of jakitinib hydrochloride 75mg BID and Acetylcysteine Effervescent Tablets; Jaktinib Dihydrochloride Monohydrate 75mg BID and Mimic tablets of jakitinib hydrochloride 50mg BID and Acetylcysteine Effervescent Tablets; Jin-shui Huan-xian granule; KD025; L - Antineoplastic and immunomodulating agents; L01 - Antineoplastic agents; L01X - Other antineoplastic agents; L01XE - Protein kinase inhibitors; L01XE31; L01XE31 - Nintedanib; LANREOTIDE ACETATE; LEBRIKIZUMAB; LPA1; Lanreotide; Lansoprazole; Lebrikizumab; Letairis; Letairis 10 mg; Letairis 5 mg; Liberase Enzyme (Roche); Losartan; Low dose BIBF 1120 twice daily; Low dose BIBF1120 once daily; Lung Spheroid Stem Cells 100 million; Lung Spheroid Stem Cells 200 million; Lung stem cells; MACITENTAN; MESNA; MG-S-2525; MONITOR; Macitentan; Medical air; Medical air (sham O2); Mesna; Minocycline; Montelukast; Morphine; Morphine Sulfate; Morphine hydrochloride; Morphine sulfate; Moxifloxacin; Mycophenolate; Mycophenolate mofetil; N-Acetylcysteine, (NAC); N-acetyl cysteine; N-acetylcysteine; NAC; NALBUPHINE HYDROCHLORIDE; ND-L02-s0201; ND-L02-s0201 for injection; NINTEDANIB; NITRIC OXIDE; Na; Nalbuphine; Nalbuphine ER; Nalbuphine Extended-Realease (ER) Tablets; Nalbuphine Extended-Release (ER) Tablets; Nandrolone; Nandrolone Decanoate; Nandrolone decanoate; Nintedanib; Nitric Oxide; Nivolumab; None; OFEV®; ORIN1001; Octreotide; Ofev; Ofev 100 mg capsule; Ofev 150 mg capsule; Omeprazole; Omeprazole (UK licensed generic product); Other: 60% Oxygen; Other: Control; Other: Cough monitor; Other: Medical air; Other: No Intervention: Standard of Care; Other: Oxygen; Other: Oxygen (2Liter/min); Other: Oxygen (4Liter/min); Other: Pulmonary rehabilitation program; Other: Standard of Care; Other: Untreated Cohort; Oxygen; Oxygen 40 %; PA101; PAMREVLUMAB; PBI4050; PD00377 Na-salt; PET/CT using PET ligands [F-18]FDG and [F-18]DPA-714; PIR, S-7701; PIRFENIDONE; PLN-74809; PLN-74809-000; PREDNISOLONE; PRIVIGEN 100mg/ml; PRM-151; PZN 8881655(RochePharma AG); Paclitaxel; Pamrevlumab; Pirfenidone; Pirfenidone and nintedanib; Pirfenidone or nintedanib; Pirfenidoneone; Placebo; Pomalidomide; Pomalidomide (CC-4047; Prednisolone; Prednisone; Procedure: IV Deployment Of cSVF In Sterile Normal Saline IV Solution; Procedure: Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF); QAX576; Quercetin; RIXATHON 500 mg; RO0220912; RO0280296; RO5490255; RO5490255/F01-02; RVT-1601; RVT-1601 (formerly, PA101B); Radiation: FDG PET scan; Radiation: GSK26346763: ([18F]-FBA-A20FMDV2) IV infusion; Radiation: Knottin tracer; Remicade; Revatio; Revatio 20 mg; Rituximab; Ro 47-0203; SAR156597; SEPTRIN; SILDENAFIL; SM04646; SODIUM CROMOGLICATE; SULFAMETHOXAZOLE; Salbutamol; Saracatinab; Septrin; Sildenafil; Sildenafil (50 mg); Sildenafil Citrate; Sildenafil and Losartan; Simtuzumab; Sirolimus; Sivelestat; Standard Steroid Treatment; Standard of Care; Sterile Normal Saline for Intravenous Use; Sub-Study: Nintedanib; Sub-Study: Pirfenidone; Sulfamethoxazole; Sulfate; Sulphamethoxazole; Symbicort; TBC; TD-1058; TD139; TNX-650, rhuMAb anti-IL13, aIL-13, MILR1444A; TR0311; TRACLEER; TRIMETHOPRIM; TRK-250; Tacrolimus; Tetrandrine; Tetrathiomolybdate; Thalidomide; Thalidomide Pharmion; The Standard Steroid Treatment, Plasma Exchange and rituximab; Thiotepa; Thrombomodulin Alfa; Thrombomodulin alfa; Tiotropium; Tipelukast; Tracleer; Traditional Chinese Medicine Formulation; Tralokinumab; Tralokinumab cohort 1; Tralokinumab cohort 2; Tralokinumab is a human recombinant monoclonal antibody (MAb) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor; Treatment as Usual (TAU); Treprostinil; Treprostinil sodium for inhalation; Trimethoprim; UROMITEXAN; Uromitexan; VAY736; VISMODEGIB; VOLIBRIS; VRP700; Valganciclovir; Vasoactive intestinal peptide; Vismodegib; Volibris; Warfarin; Xenon; ZL-2102; ZSP1603 12.5 mg; ZSP1603 25 mg; ZSP1603 50 mg; ZSP1603 7.5 mg; Zileuton; Ziritaxestat; [18F]-FBA-A20FMDV2; [18F]FP-R01-MG-F2; [68Ga]CBP8; [BG00011]; [RVT-1601 (in precedenza PA101B)]

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2012-001571-36-PL (EUCTR)	09/09/2013	17/06/2013	A study to evaluate if a new drug is effective in preventing the progression of lung fibrosis	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) - RAINIER	Idiopathic pulmonary fibrosis MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: GS-6624 INN or Proposed INN: Simtuzumab Other descriptive name: GS-6624	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 2	United States;Czech Republic;Canada;Spain;Belgium;Poland;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of
2	EUCTR2012-001571-36-DE (EUCTR)	17/06/2013	02/04/2013	A study to evaluate if a new drug is effective in preventing the progression of lung fibrosis	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER). - RAINIER	Idiopathic pulmonary fibrosis MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: GS-6624 INN or Proposed INN: Simtuzumab Other descriptive name: GS-6624	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 2	United States;Czech Republic;Canada;Poland;Spain;Belgium;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of
3	EUCTR2012-001571-36-BE (EUCTR)	28/05/2013	26/03/2013	A study to evaluate if a new drug is effective in preventing the progression of lung fibrosis	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) - RAINIER	Idiopathic pulmonary fibrosis MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: GS-6624 INN or Proposed INN: Simtuzumab Other descriptive name: GS-6624	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 2	Korea, Democratic People's Republic of;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany;Korea, Republic of;United States;Spain
4	EUCTR2012-001571-36-ES (EUCTR)	12/05/2013	16/05/2013	A study to evaluate if a new drug is effective in preventing the progression of lung fibrosis	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) - RAINER	Idiopathic pulmonary fibrosis MedDRA version: 16.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: GS-6624 INN or Proposed INN: Simtuzumab Other descriptive name: GS-6624	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 2	United States;Czech Republic;Canada;Poland;Belgium;Spain;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of
5	EUCTR2012-001571-36-CZ (EUCTR)	29/04/2013	15/04/2013	A study to evaluate if a new drug is effective in preventing the progression of lung fibrosis	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER). - RAINIER	Idiopathic pulmonary fibrosis MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: GS-6624 INN or Proposed INN: Simtuzumab Other descriptive name: GS-6624	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 2	United States;Czech Republic;Canada;Poland;Spain;Belgium;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2012-001571-36-IT (EUCTR)	26/04/2013	28/02/2013	A study to evaluate if a new drug is effective in preventing the progression of lung fibrosis	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) - RAINIER	Idiopathic pulmonary fibrosis MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: GS-6624 INN or Proposed INN: Simtuzumab Other descriptive name: GS-6624	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 2	United States;Czech Republic;Canada;Poland;Spain;Belgium;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of
7	EUCTR2012-001571-36-GB (EUCTR)	19/04/2013	28/03/2013	A study to evaluate if a new drug is effective in preventing the progression of lung fibrosis	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) - RAINIER	Idiopathic pulmonary fibrosis MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Code: GS-6624 INN or Proposed INN: Simtuzumab Other descriptive name: GS-6624	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 2	United States;Czech Republic;Canada;Poland;Spain;Belgium;Australia;Israel;Germany;Italy;United Kingdom;Korea, Republic of
8	NCT01769196 (ClinicalTrials.gov)	January 31, 2013	14/1/2013	Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF)	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)	Idiopathic Pulmonary Fibrosis	Drug: Simtuzumab;Drug: Simtuzumab placebo	Gilead Sciences	NULL	Terminated	45 Years	85 Years	All	544	Phase 2	United States;Australia;Belgium;Canada;Czechia;France;Germany;Israel;Italy;Korea, Republic of;Poland;Spain;Switzerland;United Kingdom;Czech Republic
9	NCT01759511 (ClinicalTrials.gov)	October 18, 2012	15/11/2012	Long-Term Safety Study of GS-6624 in Adults With Idiopathic Pulmonary Fibrosis (IPF)	A Phase 2, Long-Term Safety Study of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis (IPF)	Idiopathic Pulmonary Fibrosis	Drug: Simtuzumab	Gilead Sciences	NULL	Terminated	18 Years	N/A	All	34	Phase 2	United States
10	NCT01362231 (ClinicalTrials.gov)	December 2010	12/4/2011	A Study to Evaluate the Safety and Efficacy of GS-6624 (Formerly AB0024) in Patients With Idiopathic Pulmonary Fibrosis	A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis	Idiopathic Pulmonary Fibrosis	Drug: GS-6624	Gilead Sciences	NULL	Completed	40 Years	85 Years	Both	48	Phase 1	United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2012-001571-36-PL
(EUCTR)

09/09/2013

17/06/2013

A study to evaluate if a new drug is effective in preventing the progression of lung fibrosis

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) - RAINIER

Idiopathic pulmonary fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Code: GS-6624
INN or Proposed INN: Simtuzumab
Other descriptive name: GS-6624

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 2

United States;Czech Republic;Canada;Spain;Belgium;Poland;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of

EUCTR2012-001571-36-DE
(EUCTR)

17/06/2013

02/04/2013

A study to evaluate if a new drug is effective in preventing the progression of lung fibrosis

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER). - RAINIER

Idiopathic pulmonary fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Code: GS-6624
INN or Proposed INN: Simtuzumab
Other descriptive name: GS-6624

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 2

United States;Czech Republic;Canada;Poland;Spain;Belgium;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of

EUCTR2012-001571-36-BE
(EUCTR)

28/05/2013

26/03/2013

A study to evaluate if a new drug is effective in preventing the progression of lung fibrosis

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) - RAINIER

Product Code: GS-6624
INN or Proposed INN: Simtuzumab
Other descriptive name: GS-6624

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 2

Korea, Democratic People's Republic of;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany;Korea, Republic of;United States;Spain

EUCTR2012-001571-36-ES
(EUCTR)

12/05/2013

16/05/2013

A study to evaluate if a new drug is effective in preventing the progression of lung fibrosis

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) - RAINER

Idiopathic pulmonary fibrosis
MedDRA version: 16.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Code: GS-6624
INN or Proposed INN: Simtuzumab
Other descriptive name: GS-6624

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 2

United States;Czech Republic;Canada;Poland;Belgium;Spain;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of

EUCTR2012-001571-36-CZ
(EUCTR)

29/04/2013

15/04/2013

A study to evaluate if a new drug is effective in preventing the progression of lung fibrosis

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER). - RAINIER

Product Code: GS-6624
INN or Proposed INN: Simtuzumab
Other descriptive name: GS-6624

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 2

United States;Czech Republic;Canada;Poland;Spain;Belgium;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2012-001571-36-IT
(EUCTR)

26/04/2013

28/02/2013

A study to evaluate if a new drug is effective in preventing the progression of lung fibrosis

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) - RAINIER

Idiopathic pulmonary fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Code: GS-6624
INN or Proposed INN: Simtuzumab
Other descriptive name: GS-6624

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 2

United States;Czech Republic;Canada;Poland;Spain;Belgium;Australia;Israel;Germany;United Kingdom;Italy;Korea, Republic of

EUCTR2012-001571-36-GB
(EUCTR)

19/04/2013

28/03/2013

A study to evaluate if a new drug is effective in preventing the progression of lung fibrosis

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) - RAINIER

Idiopathic pulmonary fibrosis
MedDRA version: 17.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Code: GS-6624
INN or Proposed INN: Simtuzumab
Other descriptive name: GS-6624

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 2

United States;Czech Republic;Canada;Poland;Spain;Belgium;Australia;Israel;Germany;Italy;United Kingdom;Korea, Republic of

NCT01769196
(ClinicalTrials.gov)

January 31, 2013

14/1/2013

Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF)

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Idiopathic Pulmonary Fibrosis

Drug: Simtuzumab;Drug: Simtuzumab placebo

Gilead Sciences

NULL

Terminated

45 Years

85 Years

All

544

Phase 2

United States;Australia;Belgium;Canada;Czechia;France;Germany;Israel;Italy;Korea, Republic of;Poland;Spain;Switzerland;United Kingdom;Czech Republic

NCT01759511
(ClinicalTrials.gov)

October 18, 2012

15/11/2012

Long-Term Safety Study of GS-6624 in Adults With Idiopathic Pulmonary Fibrosis (IPF)

A Phase 2, Long-Term Safety Study of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Idiopathic Pulmonary Fibrosis

Drug: Simtuzumab

Gilead Sciences

NULL

Terminated

18 Years

N/A

All

Phase 2

United States

NCT01362231
(ClinicalTrials.gov)

December 2010

12/4/2011

A Study to Evaluate the Safety and Efficacy of GS-6624 (Formerly AB0024) in Patients With Idiopathic Pulmonary Fibrosis

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis

Drug: GS-6624

Gilead Sciences

NULL

Completed

40 Years

85 Years

Both

Phase 1

United States